Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004815
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werners Syndrome
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werners syndrome and osteoporosis
I Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werners syndrome and osteoporosis
Detailed Description:
PROTOCOL OUTLINE The patient receives subcutaneous recombinant human insulin-like growth factor 1 daily for 7 months The dose is adjusted according to the serum hormone level and biological markers of bone turnover
Concurrent therapy includes a metabolic diet calcium citrate and estradiol
Concurrent therapy includes a metabolic diet calcium citrate and estradiol
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTSMC-49215300 | None | None | None |